Principal Scientist Drug Substance Process Development

Job DescriptionVertex is seeking a Principal Scientist to join our Process Development group. This group offers a dynamic, fast-paced, and highly collaborative environment to make an impact. Our team focuses on bringing together the best of process design, scale-up and cutting-edge manufacturing technologies to enable the successful implementation of cell and gene therapeutics.The successful candidate will be responsible for cell therapy drug substance process scale-up, characterization and technology transfer. This role will lead a team of scientists to scale-up and optimize allogenic stem cell therapy drug substance process for commercialization. The role will lead sound experimental design to develop bioreactor cell culture, cell processing and harvest unit operations for an allogenic stem cell therapy product. The candidate will work closely with Process Development, Analytical Development, Manufacturing and Quality functions to develop and transfer manufacturing processes.Key Duties and Responsibilities:Scale-up stem cell islet DS process including bioreactor cell culture, media optimization, filtration and harvest process from clinical to commercial scale.Enhance process robustness and GMP compliance of manufacturing process by incorporating closed processing, raw material upgrades, facility fit considerations for pivotal and commercial readiness.Drive QBD based process development including process risk assessments, CPP analysis to characterize unit operations for process performance qualification.Facilitate root cause analysis, risk assessment, ideation, improvement opportunities, and next-gen technology evaluation.Collaborate with cross-functional stakeholders to drive implementation of next generation manufacturing process into GMP facility.Support IND/IMPD and BLA/MAA regulatory filings and response to agency questions.Communicate technical project updates, future process improvement proposals and risks to senior management.Lead a team of 4-5 scientists to drive lab experiments, technical reports and technical justifications to meet program goals.Train and grow team members to build a highly productive team.Flexible to perform hands-on laboratory experiments as needed to maximize resources.Required Experience:Masters or PhD degree in chemical, mechanical or bioengineering or relevant field.MS degree and 8+ years or PhD with 4+ years of experience in biotech or pharmaceutical industry.Required Knowledge/Skills:Expertise in mammalian cell culture, media screening, harvest and filtration process development from lab to pilot scale.Hands-on experience with stirred tank bioreactor process and harvest technologies e.g., counter flow centrifugation.Expertise in stem cell culture and processing e.g., iPSC, PSC, and/or knowledge of scaling cell therapy process.Adept in the application of DoEs, computational modeling and engineering principles for process scale-up and optimization.Prior experience in leading a technical team focused on upstream, downstream or drug product process for biologics or cell/gene therapy product is required.Strong verbal and written communications skills with ability to effectively communicate at multiple levels in the organization through project status meetings, presentations, and reports.Ability to adapt to evolving priorities and thrive in a dynamic and fast-paced environment.Demonstrated ability to collaborate and work effectively across team members with varied disciplines.

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